Progenics Pharmaceuticals Submits sNDA For New Delivery System

Progenics Pharmaceuticals and Wyeth Pharmaceuticals, a division of Wyeth, have submitted a supplemental New Drug Application (sNDA) to FDA, and an Extension Application to EU. It is for RELISTOR (methylnaltrexone bromide) subcutaneous injection for a new delivery system, pre-filled syringes.

RELISTOR was approved last year in single-use vials. It is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has been insufficient.

If approved, pre-filled syringes of RELISTOR are expected to be available in the US and Europe in the first half of 2010. Single-use vials of RELISTOR will continue to be available.

Paul Maddon, founder, CEO and CSO of Progenics Pharmaceuticals, said: The development of RELISTOR in pre-filled syringes is an important step in our plans to make this medication available in more convenient forms. Pre-filled syringes, containing either 8 mg or 12 mg doses of RELISTOR, will be ready-to-use, and will ease preparation and administration for patients and caregivers.